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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K260420

510(k) cleared

LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)

MacroLux Medical Technology Co., Ltd. · Apr 8, 2026 · K260420

FDA cleared the LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) from MacroLux Medical Technology Co., Ltd. on Apr 8, 2026 under K260420, a traditional 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Feb 9, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

MacroLux Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K260516 (BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)).

Questions & Answers

What did FDA clear under K260420?

K260420 is the FDA 510(k) for LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG), submitted by MacroLux Medical Technology Co., Ltd.. FDA's decision date was Apr 8, 2026, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)?

MacroLux Medical Technology Co., Ltd., based in Shenzhen, is the applicant of record for K260420.

How long did the K260420 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on Apr 8, 2026, 58 days later.

← All decisions in April 2026

Sources